MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*MCA MED APPLIER; CLIP, IMPLANTABLE

Model Number MCM20

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the analysis results found that the mcm20 device was returned with no damage.In addition, the tyvek was returned along with the instrument.Upon analysis, no damage was noted on the tyvek.The event described could not be confirmed as no damage was noted on the tyvek.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during an unknown procedure, before being used on the patient, the tyvek on the packaging was damaged, compromising the sterility of the device.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10216114
• MDR Text Key: 197174047
• Report Number: 3005075853-2020-03307
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002475
• UDI-Public: 10705036002475
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCM20
• Device Catalogue Number: MCM20
• Device Lot Number: T4118V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Date Manufacturer Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1